Agency classClass IIOur severity:High FDA (Devices)·Z-1740-2014·Announced 2014-06-18

Ivoclar Vivadent Recalls Bluephase Style Light Probes Due to Broken Glass Fibers

Ivoclar Vivadent is recalling 241 Bluephase style light probes because a stock check revealed broken glass fibers between the connector and the fiber bundle.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a physical defect (broken glass fibers) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 241 units of the Bluephase style Light probe Pin-point 6>2 mm black (Reference # 636 241). This accessory is a pin-point light probe used with dental curing lights for ultraviolet activation during dental procedures. The recall covers all lots of this specific reference number.

The recall was initiated after a stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes. The affected products were distributed nationwide in the United States and in Canada.

Dental professionals and patients should stop using the affected light probes immediately. Consumers should contact Ivoclar Vivadent, Inc. for further instructions on how to return or replace the devices.

The recalled product

Product: bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing.
Manufacturer: Ivoclar Vivadent, Inc.
Category: Medical Device — Dental Equipment
Hazard: broken-glass
physical-defect
Affected units: 241

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Reference number 636241
all lots

Distribution

Distributed nationwide across the United States.

Same manufacturer · Ivoclar Vivadent, Inc.

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Same hazard · broken glass